Dermabrasion generally consists of removing the epidermis and superficial layers of the dermis. Dermabrasion can be used as a therapeutic process for several skin conditions. In particular, indications for dermabrasion include acne scarring, active acne, nasal rhinophyma, traumatic or surgical scarring, tattoos, lentigenes, facial rhytids, keratoses, and more recently, wrinkles caused by natural aging. This has been additionally discussed in U.S. patent application 20030113540 (Anderson et al.).
Resurfacing the human skin can be achieved by several mechanisms that are aimed primarily at disrupting the epidermal and upper dermal layers. Human skin is composed of at least three layers of variable thickness, depending upon body location. The uppermost layer, or epidermis, is usually as thin as a sheet of paper. The layer just below the epidermis is the dermis, which is largely composed of collagen and makes up the “leather” layer of the skin. The dermis may vary in thickness from that of paper to as thick as half an inch on the neck and back. The layer below the dermis may be composed of either muscle (around the eyes and mouth) or fat, otherwise known as subcutaneous fat. New human surface skin is regenerated following resurfacing by the surrounding islands of normal epidermis and epidermal cells migrating from the deep hair pores and other pore structures that permeate the upper dermis, mid dermis, and epidermis. If excessive scar tissue, rather than a plethora of epidermal cells, closes a surface wound, then an unsightly scar will result. The key to all resurfacing procedures is a controlled destruction of the desired area that still allows the regeneration of new tissues from pores and neighboring islands of untouched, untreated skin.
The procedures currently used in human skin resurfacing include chemical peeling, dermabrasion, laser surgery, and most recently the “power peel” or crystalline peel. In chemical peeling, a caustic, disruptive or destructive liquid agent is applied to the surface skin to damage existing epidermal and dermal cells, which will then be replaced by the body. Peeling agents act depending on their strength and type. Examples of chemical peeling agents include fruit acid peel, glycolic acid peel, and trichloracetic acid (TCA) and phenol peels. TCA peels can be made to act at deeper and varying depths by varying the concentration of TCA used to destroy the surface skin. Concentrations as low as 5–10% TCA will behave similarly to a fruit acid peel, and concentrations of 50% TCA may cause severe peeling burns, which simulates phenol, and may border on scarring. Phenol, when diluted with water, penetrates more deeply and destroys more tissue than most other peeling agents.
Dermabrasion literally means abrasion of the skin and is a procedure in which a rotating sanding wheel, or abrasive substance, is applied to a rigidified skin to sand out an undesirable feature, mark, or scar. Some high-speed dermabrasion rotors go up to 200,000 revolutions per minute (rpm) and do not require any rigidity to the tissues; however, they require extremely skilled personnel and special instrumentation and are impractical for most home use. A minor mistake with such a high powered machine can have disastrous results. Dermabrasion is usually performed with a rotating wheel operating at speeds under 10,000 rpm after the skin has been rigidified using Freon or dichlorotetrafluoroethane. In dermabrasion (unlike laser surgery), the person operating the abrading wheel has a direct tactile sense of pressing the wheel into the tissues being treated and can apply differential pressure to areas of elevation. Dermabrasion can be achieved to various depths depending upon the depth of freezing (rigidification), the number of passes of the abrader, the type of abrasive wheel, and the pressure applied. This procedure is waning in use, however, due to the unavailability of Freon.
Presently, dermabrasion is carried out by utilizing powered air-driven units. Such units include a tip that rotates at high speed, for example, 600 to 35,000 RPM. The tip receives a sanding bit, which is rotated by the tip while it is pressed against the dermis of a patient. In this way, the epidermal layer of skin may be removed, which effects removal of superficial scars of the skin and improvement in appearance of intermediate depth scars. Following dermabrasion, a new layer of epidermis forms at a depth lower than that of the original epidermis. Dermabrasion may be carried out several times to treat deep scarring of the skin. Despite the efficacy of utilizing powerful airdriven units according to the prior art, such units have several drawbacks. For example, such units are both costly and relatively complex and impractical for home use by consumer. This has been further discussed in U.S. Pat. No. 5,800,446 (Banuchi). Several other machines and apparatus have recently been devised for dermabrasion, for example U.S. Patent Applications 20030130628 (Duffy), 20030125660 (Moutafis et al.), 20030097139 (Karasiuk), 20030093089 (Greenberg), 20020169461 (Simon et al.), 20020133176 (Parkin et al.), 20020128663 (Mercier et al.), 20020107529 (Bernabei), 20020040199 (Klopotek), 20020016601 (Shadduk), 20020107527 (Burres) 20010034519 (Goble et al.), 20010023327 (Hill), and 20010049511 (Coleman et al.). These all are also very complex and not useful for in-home application by consumer.
In a new technique referred to as crystal microdermabrasion, aluminum oxide (corundum) crystals flowing in an air stream have been applied to the skin. In this technique, there is less bleeding, fewer complications, better compliance, and no need for local anesthesia or high surgical skills. In the microdermabrasion technique, the velocity and density of crystals within the stream of air is related to the degree of abrasion which can occur over a fixed period of time. In the past, the crystal velocity has been controlled primarily by providing a bleed valve for the introduction of additional air into the stream of air. In a suction system this tends to slow the velocity of the operative air stream and thereby reduce the degree of abrasion. U.S. Pat. No. 6,592,595 (Mallet et al.) describes these techniques in further detail. Again, such units are costly and relatively complex. U.S. Patent Application 20020090385 (Fox et al.) discloses microdermabrasion with a crystalline emulsion. The crystalline emulsion includes a mixture of coated crystals and a carrier. The coated crystals are formed by combining magnesium oxide, aluminum oxide or a combination of the two with methicone, adding a catalyst, such as ammonia, and mixing, then baking the resulting slurry mixture until the mixture is dry. The coated crystals are able to stay in the emulsion in a carrier.
The power peel is relatively new in the United States and is basically a method of “sandblasting” the skin. This procedure has been touted to reduce acne scars and remove all other types of scars and imperfections. The power peel is a process by which aluminum oxide crystals, which are extremely hard, are shot at the skin with 25 psi of air pressure. Safe operation of these devices requires the use of a limited number of passes or accurate control of pass speed to the target area. A power peel that only removes the epidermis of the skin will not result in any alteration of scar formation and produces very little long-lasting cosmetic effect. However, aluminum oxide crystals that are shot deeply enough into the skin to remove or alter deeper structures such as scars or pits can cause granuloma formation or foreign body reaction because aluminum oxide crystals are not biocompatible. Thus the body extrudes or encapsulates unwanted particles at levels of skin where protection is necessary, which may lead to disease and unsightly scarring. Even systems that include a vacuum apparatus to suck away unwanted particles do not remove 100% of the particles. Even a small amount of residue crystals can lead to disease and other cellular difficulties. U.S. Pat. No. 6,306,119 (Weber et al.) further discusses this topic. Another variant of this methodology, i.e. the use of solid particles such as sand, alumina, or hard fibers, etc. is disclosed in U.S. Pat. No. 6,017,351 (Street) in which a cosmetic pad for use in removing surface detritus from the skin at pressures a lay person can apply in scrubbing the skin is comprised of a segment of lofty, fibrous, non-woven structure of mixed denier organic (e.g., nylon or polyester) crimped filaments bonded at contacting points with a binder such as thermosetting resin and containing finely divided, biocompatible, soft abrasive particles. This is essentially equivalent to the use of sand paper or emery cloth for dermabrasion. This method does not permit dermabrasion to any precise depth and can be painful.
Another dermabrasion technique is generally known as “tape stripping” and involves adhering a tape having a pressure-sensitive adhesive backing to the user's body and then pulling the tape off the body part to remove an outer layer of skin. Of particular note is U.S. Pat. No. 5,720,963 wherein Smith teaches a variety of long term skin treatments, several of which include a regime of five to ten tape stripping steps repeated twice daily in order to chronically disrupt a skin water barrier. Smith also teaches that more severe treatments can be carried out less frequently (e.g., every second or third day) by using a more aggressive skin-adhering adhesive, such as a cyanoacrylate adhesive. Although he discloses several different tape stripping approaches in U.S. Pat. No. 5,720,963, Smith states that his tape stripping method has numerous draw-backs, which include a wide range of response of various individuals to tape stripping, as well as a stated need for an expensive laboratory instrument to monitor the process. Moreover, Smith's teaching is directed entirely towards treatments extending over several months before obtaining discernible results. U.S. Pat. No. 6,290,659 (Hill) discloses yet another method of practicing the skin exfoliation comprises the steps of: 1) preparing a transparent exfoliation sheet having an adhesive-covered portion comparable in size and shape to a portion of the user's body that is to be exfoliated and attaching a handle along one edge of the sheet; 2) adhering that portion of the exfoliation sheet immediately adjacent the handle to a first edge of the predetermined portion of the body; 3) rubbing or pressing on the exfoliation sheet by moving one's hand or fingers from a staring position adjacent the handle toward that edge of the exfoliation sheet distal from the handle so as to attach substantially the entire sheet to the predetermined portion of the body by means of the pressure sensitive adhesive; 4) grasping the handle and pulling it along the surface of the predetermined portion of the body so as to separate the first exfoliation sheet from the portion of the body being exfoliated; 5) visually examining the removed first transparent exfoliation sheet to determine the amount of skin exfoliated; 6) preparing a new exfoliation sheet and repeating steps 1) through 5) until the amount of exfoliated skin noted at an ending repetition is discernibly less than the amount of exfoliated skin retained on the respective exfoliation sheet employed in the immediately preceding repetition. None of these “skin stripping” methods provide a complete solution to excess skin removal and rebuilding of normal skin surface.
Dermal scratching is another method practiced for dermabrasion, as disclosed in U.S. Pat. No. 5,454,384 and U.S. Pat. No. 5,012,797 (McAllister) wherein a target line or wrinkle is selected that the patient wishes to minimize or eradicate. A pair of lines is scratched in the skin parallel to and one on each side of the target line. Preferably two series of lines are then scratched in the skin, one series parallel to each of the first pair of lines, with a separation of at least 1/16 inch. The post-treatment steps include cleaning the scratches with antibacterial soap, drying the area, and massaging with antibacterial topical cream. Once the lines scratched in the skin are permitted to heal, the skin is found to be tightened. This method is suitable for application by a surgeon or dermatologist and not convenient for in-home use by consumer.
Laser surgery has recently become popular to remove or reduce wrinkles, remove tumors, and alter scars, although results are mixed. Several types of lasers are used, including carbon dioxide and erbium-YAG lasers. Carbon dioxide lasers deliver light radiation at a frequency that can vaporize and destroy surface skin. These lasers may be set on various pulse patterns to deliver precise and controlled amounts of laser radiation to the skin in a relatively uniform and homogenous fashion across the surface. An unfortunate disadvantage of this laser is that heat can be transmitted to the surrounding tissues. Additionally, after the first pass of the carbon dioxide laser, the skin begins to ooze and become wet at the surface as fluids build up in response to the damage. Since water and blood absorb in the infrared region, a second pass of the laser will penetrate to a variable depth, depending on how much surface ooze there is in the area. The ooze prevents the laser energy from reaching the target tissues uniformly. During laser irradiation, the tissues may begin to desiccate, which ultimately results in severe thermal damage. Depositing too much laser energy on the target tissues can result in persistent redness, scarring, and other complications or damage, even with thermal relaxation techniques to mitigate heat transfer. U.S. Pat. No. 6,077,294 (Cho et al.) discloses a method for the treatment of wrinkles on human skin, by stimulating collagen growth beneath the epidermis layer, comprising the steps of: arranging a pulsed dye laser generator in light communication with a pulsed dye laser delivery device. Laser methods require the services of a plastic surgeon or dermatologist and are expensive and not convenient.
After dermabrasion the rebuilding of skin requires recollagenation. Disfiguring cutaneous irregularities, such as acne scars, wrinkles, and post traumatic depressions are a consequence of the loss of collagen that supplies the tissue thickness and maintains an even surface contour. Re-collagenation is the rebuilding of this lost collagen. Materials that have been used clinically to replace the lost tissue volume by subcutaneous injection include liquid silicone, fat, paraffin, liquid bovine collagen, and other fibrin compounds. Collagen suspensions, such as the liquid bovine collagen disclosed in U.S. Pat. No. 4,424,208 (Wallace et al.), U.S. Pat. No. 4,582,640 (Smestad et al.), and U.S. Pat. No. 4,642,117 (Nguyen et al.) are problematic in that they routinely fail to add endogenous collagen to tissue. Over time, the liquid disperses between cells allowing intercellular collagenase to digest the collagen substrate. Fat transferred from other areas is lumpy and has an unpredictable pattern of reabsorption. More resilient materials like silicone are gradually excreted into neighboring tissues from the depressed areas as the scar tightens again. Substances like paraffin can initiate an inflammatory response that causes further collagen loss. These filling techniques, in which liquid materials are injected through a needle into the scar, are disadvantageous because an injectable substance does not create a space between the layers of tissue in the recipient scar bed and therefore does not initiate new collagen deposition. U.S. Pat. No. 5,397,352 (Burres) discloses a surgical method for implanting cadaver collagen for the restoration of lesions caused by the loss of collagen. The skin is perforated and a pocket is created under the skin. Human cadaver collagen is then introduced into the pocket and the skin perforation is closed. Over the next several months, the cadaver collagen is replaced by endogenous collagen. U.S. Pat. Nos. 4,061,731 and 4,006,220 (Gottlieb) discloses the use of fibrin stabilizer and plasma for collagen rebuilding, wherein said fibrin stabilizer is present in an amount effective to maintain fibrin within a cavity preferably formed under said scar. One fibrin stabilizer used is finely-divided collagen. The compositions promote the build-up of new collagen within the aforementioned cavity.
The above prior art citations clearly establish that dermabrasion has distinct advantages in treating skin conditions such as acne scars, wound scars, disfigurements of skin from diseases such as small pox, and other skin disfigurements. It is also clear from the above prior art citations that it would be advantageous to develop a procedure that can remove scars, wrinkles, and various other imperfections or lesions on the skin without introducing foreign bodies or substances that can cause adverse physiological reactions or produce unwanted physical or thermal damage or discomfort.
It is also clear from the above prior art citations that treatment of such skin disfigurement conditions ideally requires the following three steps, (1) removal of excess skin surface by abrasion (2) polishing of abraded skin surface to smoothen it, and (3) re-building of abraded skin by enhancement of collagen synthesis and boosting of other skin fibers. In addition, the inclusion of an anti-inflammatory agent to soothe the skin, blood microcirculation enhancement agent to bring additional blood carrying skin nutrients and oxygen (to further promote skin rebuilding), and an emollient to seal the skin from excessive moisture loss from freshly exposed skin surface would also be highly beneficial.
It is also clear from the above prior art citations that no such comprehensive skin treatment systems currently exist, although their usefulness and consumer desirability is obvious to those who are versed in this art.
The present invention provides a novel solution to this problem by using a complementary three-step treatment process that does not require any expensive machine or apparatus, unsafe or harsh chemical, or services of a trained professional or physician. This three-step treatment can be self-administered easily at home by consumer. This three-step dermabrasion system of the present invention constitutes the following, (1) Dermal Resurfacing with an adhesive gel, (2) Dermal Polishing with a polishing composition, and (3) Dermal Regeneration with a collagen-building and cell-proliferative composition with the inclusion of anti-inflammatory agents and emollients.